(59 days)
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No
The device is described as a compomer luting cement and the performance studies focus on material properties and comparison to a predicate cement, with no mention of AI/ML.
No
The device is a dental luting cement used for bonding restorations, which is not considered a therapeutic function based on the provided information.
No
Explanation: The device is described as a luting cement intended for final cementation of restorations. Its function is to secure dental restorations, not to diagnose medical conditions or diseases.
No
The device description clearly states it is a "compomer luting cement," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the final cementation of dental restorations (crowns, bridges, etc.). This is a direct application within the body (or on a structure that will be placed in the body), not for testing samples taken from the body.
- Device Description: It's a compomer luting cement, which is a material used for bonding in dentistry.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the body (blood, urine, tissue, etc.), diagnostic purposes, or any of the typical characteristics of an IVD.
IVDs are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device's function is purely for physical bonding in a dental context.
N/A
Intended Use / Indications for Use
Hycem® Aplicap® is intended for final cementation of restorations composed of all classes of materials, including for cementation of crowns, bridges, inlays/onlays, pins and screws, and brackets and bands.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.
0
NOV 1 5 1996
K963737 II. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
ESPE is submitting a 510(k) premarket notification for its compomer luting cement, tradenamed Hycem® Aplicap®. Hycem® Aplicap® is intended for final cementation of restorations composed of all classes of materials, including for cementation of crowns, bridges, inlays/onlays, pins and screws, and brackets and bands.
ESPE is claiming substantial equivalence to Dentsply Caulk's Advance™ Hybrid Ionomer Cement. These products have the same intended use and similar composition.
To support the substantial equivalence to predicate products, the composition and the physical and technical characteristics of Hycem® Aplicap® have been compared to those of Advance™ Hybrid Ionomer Cement. Hycem® Aplicap® meets the requirements of relevant DIN and ISO standards for dental cement.
ESPE's 510(k) has been submitted on September 17, 1996 by Dr. Barbara Wagner at Am Griesberg 2, D-82229 Seefeld, Germany (011-49-8152-700395).